Quality Specialist I (Complaints Investigations)
Onsite Location(s): Cork, IE
Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance
At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges.
With access to the latest tools, information and training, we'll help you in advancing your skills and career.
Here, you'll be supported in progressing – whatever your ambitions.
Advancing possibilities for a brighter tomorrow
We are seeking a
Quality Specialist I
on a
permanent
basis to join our team.
Job Purpose
The Complaints Investigator will be responsible for investigating customer complaints related to pharmaceutical products, ensuring thorough documentation of findings within MasterControl.
The role requires high attention to detail, excellent documentation skills, and the ability to work independently and collaboratively across teams.
The successful candidate will support the maintenance of quality standards and regulatory compliance, contributing to continuous improvement in complaint handling processes.
Key Responsibilities
Investigate and document customer complaints for pharmaceutical products to a high standard within MasterControl.
Conduct root cause analysis and risk assessments as part of complaint investigations.
Collaborate with cross-functional teams (Quality Assurance, Pharmacovigilance, Regulatory, Operations and Technical Team) to resolve product issues and support process improvements.
Ensure compliance with relevant cGxP regulatory requirements and internal procedures.
Prepare clear, accurate, and timely investigation reports and maintain complete records of all complaint activities.
Present findings and compliant processes during internal and external audits.
Participate in training programs, including an initial ***** week period in Farnham, UK.
Support continuous improvement initiatives in complaint handling and documentation.
Maintain up-to-date knowledge of pharmaceutical quality systems, regulatory requirements, and industry trends.
Support the Pharmaceutical Quality System team initiatives and activities.
Initiates and writes/updates required procedures to support activities.
Identifies deviations from standard practices, evaluates their impact, and determines corrective actions.
Requirements
Level 8 Honours Bachelor Degree in Quality or related discipline.
3+ years' experience working in Pharmaceutical industry (Ideally in a QA role)
Excellent understanding and hands-on working knowledge of cGMP, quality and regulatory requirements.
Previous experience in a Quality, or Manufacturing background, particularly in relation to pharmaceutical quality systems.
Strong communication skills, both verbal and written, with good interpersonal skills.
Skilled in using Microsoft Office applications.
Demonstrated ability to work with cross functional organizations in a dynamic manufacturing environment to solve problems.
Working knowledge and understanding of FDA, HPRA, and the pharmaceutical industry quality requirements and associated manufacturing controls desirable.
Experience in problem solving and process improvement methodologies desirable.
Post Market, Complaint investigation and CAPA experience desirable.
As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life.
Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate.
Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.
So, choosing a career with Boston Scientific isn't just business, it's personal.
And if you're a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!
Boston Scientific is proud to be an equal opportunity and affirmative action employer.
Boston Scientific is committed to providing reasonable accommodations for applicants and employees with a disability.
Should you require a reasonable accommodation during the recruitment process, please email
******
Job Segment:
Pharmaceutical, Quality Assurance, QA, Compliance, Science, Technology, Quality, Legal, Customer Service
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